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Mirvaso has been approved by the FDA.

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  • #16
    Originally posted by jrlhamcat2 View Post
    I've just seen that it's indicated for erythema. I haven't seen anything specifying whether it's for transient erythema (flushing) or non-transient erythema (fixed redness). Have I missed something? Regardless, I'd assume that it can help with both because of the mechanism.
    According to what I read and what David stated it's for non transient redness which is good news for many but doesn't help me as I tend to flush a lot so it comes and goes. That would be a bonus if it ends up helping with both.

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    • #17
      If its going to be released in US next month will it also be being released in Australia at that same time or should i expect to be waiting for a while?

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      • #18
        I spoke to a doctor that is running one of the trials for Mirvaso here in the UK, this doctor advised me that Mirvaso was not intended to treat the flushing associated with Rosacea but in many cases had helped patients with this problem.

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        • #19
          That is awsome news man😃i hope that i'll hold such a cream in my hand next month. That would be amazing. Winter time is coming soon, and this time isn't the best one for sufferers with red faces😉i it's out next month i hope it's possible to order it somehow to deliver it overseas?😳

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          • #20
            I really hope that it is available very soon on the NHS here in the UK! The current clinical trials are only 8 days long so ultimately I would have thought all results from the current Phase 3 trial (PROOF) would have been collated by the end of September/October.

            Just a reminder that for UK users the following website appears to be updated regularly with approval information etc:

            http://www.ukmi.nhs.uk/applications/...newDrugID=5932

            As you can see the page has already been updated to reflect the US approval.

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            • #21
              This is so exciting!!!! But, I can't help notice all the adverse reactions with flushing (10%) being the highest. If it only last 12 hours and they recommend once daily, have they not solved the rebound issue? Gosh - I am in the US, will try the product, but hate to be the guinea pig. Does anyone know if/how rebound was addressed?

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              • #22
                Also - can someone explain to me why it WOULDN't help with flushing. If it constricts the blood vessels, that would help with flushing, right? Same way AC or fans do? I don't see what the difference is. I do suffer baseline redness (for dilated blood vessels) and flushing - when they dilate further or others ones dilate. So - I am confused how it could treat redness but not affect flushing in a positive way (minus the rebound potential). ???? Any thoughts?

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                • #23
                  Originally posted by jlb2010 View Post
                  This is so exciting!!!! But, I can't help notice all the adverse reactions with flushing (10%) being the highest. If it only last 12 hours and they recommend once daily, have they not solved the rebound issue? Gosh - I am in the US, will try the product, but hate to be the guinea pig. Does anyone know if/how rebound was addressed?
                  they appear to have fixed it as the 10% flushing is only to be found within the 1% of those who suffer adverse reactions to the gel. As to the flushing it seems likely that it would positively effect it.

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                  • #24
                    Hi everybody,

                    Today i went to see my dermatologist. He said to me that there is only 2 solutions for flushing: laser (with didn't do anything for me and a new product that he didn't know the name (mirvaso). He told me that he went in a congress a couple of months ago and he was very impress with mirvaso. He told me that mirvasso speaker said that with that medication maybe the laser will disapeard since mirvaso is very powerfull. He insisted that it will help with flushing (my main problem).

                    I was very encouraged with that news. I wanted to share that with all of you. Since i'm from Canada, mirvaso will have another name and it will be available around february 2015! Can't wait.

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                    • #25
                      Originally posted by mr_after View Post
                      Hi everybody,

                      Today i went to see my dermatologist. He said to me that there is only 2 solutions for flushing: laser (with didn't do anything for me and a new product that he didn't know the name (mirvaso). He told me that he went in a congress a couple of months ago and he was very impress with mirvaso. He told me that mirvasso speaker said that with that medication maybe the laser will disapeard since mirvaso is very powerfull. He insisted that it will help with flushing (my main problem).

                      I was very encouraged with that news. I wanted to share that with all of you. Since i'm from Canada, mirvaso will have another name and it will be available around february 2015! Can't wait.
                      2015 or 2014?

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                      • #26
                        I would also like to know if you meant 2014 rather than 2015.

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                        • #27
                          Originally posted by Henrik1967 View Post
                          Will there be any ways for sufferers outside of America to get Mirvaso next month? I am currently based in Australia. Thanks
                          I think it will be quite difficult, it not impossible to source Mirvaso in the next few months if you don't live in the US.

                          If don't have access to a doctor who can prescribe it and also don't have the ability to pay for it, Mirvaso will remain very difficult to source.
                          Get Rosacea News here - https://rosacea-support.org

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                          • #28
                            Originally posted by maskielli View Post
                            If its going to be released in US next month will it also be being released in Australia at that same time or should i expect to be waiting for a while?
                            There is no information available on when/if it will be released in Australia.

                            So if one wants to speculate ....

                            It is entirely up to Galderma to decide how to tackle the Australian market. They can decide to try to get it listed on the PBS or make it available unsubsidised. A lot will depend on how well they can show that it is novel and worth the Australian Government subsidising it. Perhaps there is an argument that because it is the only approved topical treatment for rosacea redness it should be listed on the PBS. That path would take in the years timeframe.

                            For eg. see that Oracea and Metrogel 1% are not available in Australia, I suspect mostly because they are not significantly better than the already available alternatives so would never get on to the PBS.

                            That all assumes it is a priority for Galderma. The European market is so much bigger and they do seem to be more advanced in their approval process for Europe so my guess is that Australia will be well behind Europe for the availability of Mirvaso.
                            Get Rosacea News here - https://rosacea-support.org

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                            • #29
                              i meant 2014 for Canada. Next month for usa. Sorry

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                              • #30
                                Does someone know when its aveilable in switzerland?

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